Controlled Trial of High-risk Coronary Intervention With Percutaneous Left Ventricular Unloading (CHIP-BCIS3)
Over 100,000 coronary stent procedures, where small balloons are used to stretch open a narrowed blood vessel, are performed every year in the United Kingdom to treat people who have conditions such as angina or have suffered a heart attack.
For most patients the risk of complications is low, but for some, there is a higher risk of their heart failing during the procedure. Heart failure is a serious complication which can need treatment with a life support machine and lead to major damage to the heart muscle or even death. These risks are greatest in patients with severely diseased heart arteries and those who already have weakened heart muscle.
A new technology may be able to help with this problem. It consists of a small heart pump which is placed in the heart's main pumping chamber (the left ventricle, LV). This pump is known as a LV unloading device. The LV unloading device is inserted into the heart through a blood vessel in the leg and supports the heart muscle. It is removed at the end of the procedure or when the heart can pump safely on its own. Whilst this heart pump is promising, it comes with some risks of its own. These include bleeding and damage to the arteries in the legs. It is also expensive, costing £8,000 per operation. Currently, there is no strong evidence to guide the use of this device.
The CHIP-BCIS3 study aims to determine whether these heart pumps are beneficial and cost-effective in patients receiving a stenting procedure who are at high-risk of complications.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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London, United Kingdom, SE1 7EH
- Guy's and St Thomas' NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Extensive coronary disease defined by a British Cardiovascular Intervention Society (BCIS) Jeopardy Score ≥ 8*
- Severe left ventricular systolic dysfunction defined as a LVEF ≤ 35% (or ≤ 45% in the presence of severe mitral regurgitation)#
Complex PCI defined by the presence of at least one of the following criteria:
Unprotected left main intervention in the presence of
- an occluded dominant right coronary artery, or
- a left dominant circulation, or
- disease involving the entire bifurcation (Medina 1,1,1 or 0,1,1)
Intended calcium modification (by rotational or orbital atherectomy, lithotripsy or laser)
- in multiple vessels or
- in the left main stem, or
- in a final patent conduit, or
- where the anatomic SYNTAX score is ≥32
Target vessel is a chronic total occlusion with planned retrograde approach
In general, patients who do not have bypass grafts will be eligible if the patient has at least proximal left anterior descending (LAD) disease or at least proximal 2 vessel disease. For patients with patent bypass grafts, or in cases where the extent of coronary artery disease (CAD) is uncertain, the BCIS-1 JS should be calculated. The maximum possible JS score is 12. N.B. The JS should be based on all coronary disease, not just the vessel subtending viable myocardium.
- Biplane / 3D echocardiography, or cardiac MRI can be used to assess the qualifying LVEF.
Exclusion Criteria:
- Cardiogenic shock or acute STEMI at randomisation (including current treatment with a mechanical circulatory support device)
- Contraindication to pLVAD insertion
- Inability to give informed consent
- Previously enrolled in CHIP or current enrolment in another interventional study that may affect CHIP outcomes
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: LV-unloading
Participants in the elective unloading (intervention) group will have a percutaneous left ventricular unloading device (pLVAD) inserted at the start of the procedure, before the coronary intervention.
Maximal support will be provided throughout the procedure, following which support will be weaned and the device removed should the patient remain haemodynamically stable.
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Percutaneous left ventricular unloading involves the placement of a mechanical pump which draws blood from the left ventricle and returns it into the aorta at flow rates approaching native cardiac output.
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No Intervention: Standard of Care
Participants in the control arm will receive the planned high-risk percutaneous coronary intervention as is the current standard of care without elective left ventricular unloading.
Alternative mechanical circulatory support devices (such as the intra-aortic balloon pump (IABP) or extracorporeal membrane oxygenation (ECMO) will only be permitted in case of complications.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Composite hierarchical outcome analysed using a Win Ratio method.
Time Frame: Minimum 12-months of follow-up, up to 51 months
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Events included in the composite hierarchical outcome include: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial infarction.
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Minimum 12-months of follow-up, up to 51 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Resource utilisation and cost effectiveness measured by incremental costs
Time Frame: At 12-months post-randomisation
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At 12-months post-randomisation
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Resource utilisation and cost effectiveness measured by quality-adjusted life years (QALYs)
Time Frame: At 12-months post-randomisation
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At 12-months post-randomisation
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Resource utilisation and cost effectiveness measured by net monetary benefit
Time Frame: At 12-months post-randomisation
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At 12-months post-randomisation
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Individual components of the primary outcome including: death, stroke, spontaneous myocardial infarction, cardiovascular hospitalisation or periprocedural myocardial injury.
Time Frame: Minimum 12-months of follow-up, up to 51 months
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Analysis will include repeated occurrences of these events
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Minimum 12-months of follow-up, up to 51 months
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Completeness of revascularisation measured by the change in anatomic BCIS-JS score
Time Frame: Between baseline and the completion of the final planned PCI procedure, up to a maximum of 1 year
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Between baseline and the completion of the final planned PCI procedure, up to a maximum of 1 year
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Completeness of revascularisation measured by the change in anatomic SYNTAX score
Time Frame: Between baseline and the completion of the final planned PCI procedure, up to a maximum of 1 year
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Between baseline and the completion of the final planned PCI procedure, up to a maximum of 1 year
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Major bleeding using the Bleeding Academic Research Consortium (BARC 3 to 5) classification
Time Frame: At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up
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At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up
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Vascular complication measured using VARC criteria
Time Frame: Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year
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Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year
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Procedural complication measured as the incidence of VT/VF requiring defibrillation, cardiorespiratory arrest, acute pulmonary oedema requiring assisted ventilation or prolonged hypotension
Time Frame: Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year
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Post-procedural at each planned percutaneous coronary intervention procedure, up to a maximum of 1 year
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Unplanned revascularisation
Time Frame: At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up
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At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up
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Health-related quality of life and functional status measured by the EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L)
Time Frame: At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up
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The EuroQol 5-Dimension 5-level questionnaire (EQ-5D- 5L) measures quality of life and functional status with higher scores indicating better outcomes.
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At 90 days, 1, 2, 3 and 4 years post-randomisation, up to a maximum of 51 months of follow-up
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Acute kidney injury
Time Frame: At 90 days post-randomisation
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Defined as prolongation hospital admission or readmission ≥ 24 hours with rise in creatinine to 200% of baseline value or need for new renal replacement therapy within 30 days of procedure
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At 90 days post-randomisation
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Serial cardiac troponin (T or I) levels
Time Frame: At baseline, 6 and 24 hours post-procedure
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Measured by immunoassay
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At baseline, 6 and 24 hours post-procedure
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Length of stay
Time Frame: Up to a maximum of 1 year
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Measured by the duration of admission in complete days following the index PCI procedure and any subsequent planned staged PCI procedure
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Up to a maximum of 1 year
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Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Divaka Perera, KCL, GSTT
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS290599
- 130593 (Other Grant/Funding Number: NIHR HTA CET)
- 17730734 (Registry Identifier: ISRCTN)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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